SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism

NCT07482020 | Recruiting Phase 2 DMC

• 1 other identifier: SGLT2i in AF
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure is the most important clinical endpoint event in atrial fibrillation (AF). Patients with AF complicated by heart failure have a significantly higher risk of all-cause mortality and cardiovascular mortality compared to those without heart failure. Abnormal left atrial function is an important mechanism leading to the occurrence of AF-related heart failure. Therefore, it is essential to find drugs that can improve left atrial function to prevent heart failure in patients with AF. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are important drugs for regulating metabolic abnormalities. Studies have found that these drugs also reduce the risk of new-onset AF in patients with heart failure. Thus, the investigators hypothesize that SGLT2i may be able to regulate left atrial function. This study is a multicenter randomized controlled trial using three-dimensional speckle tracking echocardiography to investigate whether SGLT2i can improve left atrial function and prevent heart failure in patients with paroxysmal AF who have hypertension and metabolic disorders, compared to placebo. The investigators also observed the effects of SGLT2i on cardiovascular and metabolic risk factors. The investigator team has a solid foundation in the field of cardiovascular metabolism, having completed the evaluation of left atrial function in paroxysmal AF using three-dimensional speckle tracking technology over the past three years. This study is the first to propose that SGLT2i can improve left atrial function in paroxysmal AF patients with metabolic abnormalities, which is of great significance for preventing heart failure in this type of AF.

Conditions

Atrial Fibrillation (AF); Hypertension

Keywords

SGLT2 inhibitor; atrial fibrillation; hypertension

Outcome Measures

Primary Outcomes (1)

• LA strain （LASI）

  Using three-dimensional speckle tracking technology to measure longitudinal strain during the reservoir phase (LASr).Using TDI to measure E/e'. The LASI is calculated by these two parameter and can indicate left atrial strain.

  from enrollment to the end of treatment at 12 months

Secondary Outcomes (6)

• circumferential strain (LASr-c)

  From enrollment to the end of treatment at 12 months

• conduit phase (LAScd)

  From enrollment to the end of treatment at 12 months

• hospitalization due to heart failure

  From enrollment to the end of treatment at 12 months

• changes in blood pressure

  From enrollment to the end of treatment at 12 months

• change in blood glucose

  From enrollment to the end of treatment at 12 months

Study Arms (2)

SGLT2 i TREATMENT

ACTIVE COMPARATOR

Drug: SGLT-2 inhibitors

PLACEBO

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SGLT-2 inhibitors DRUG

empagliflozin (10mg qd)

SGLT2 i TREATMENT

Placebo DRUG

PLACEBO

PLACEBO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years, treated in the outpatient or inpatient departments of each research center and included in the AF database.
• Patients with paroxysmal AF confirmed by 12-lead electrocardiogram, 24-hour Holter monitoring, or handheld electrocardiogram devices.
• Patients with hypertension who have already started antihypertensive treatment.
• Patients with diabetes who have already started antidiabetic treatment, or patients with prediabetes who have not received antidiabetic treatment but have an HbA1c level within the range of 6.1-6.4% in the past three months.

You may not qualify if:

• Atrial fibrillation caused by severe mitral stenosis.
• Atrial fibrillation with severe mitral regurgitation and severe tricuspid regurgitation.
• Patients who have been clinically diagnosed with heart failure (heart failure with preserved ejection fraction or heart failure with reduced ejection fraction).
• Special types of cardiomyopathy: amyloid cardiomyopathy, Fabry disease, muscular dystrophy, hypertrophic obstructive cardiomyopathy, etc.
• Patients with a history of myocardial infarction within the past three months.
• Pregnant women.

Sponsors & Collaborators

• Huashan Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator

Study Sites (1)

Fudan University Affiliated Huashan Hospital, Cardiology Department

Shanghai, Shanghai Municipality, 200036, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Central Study Contacts

Liwen Bao, MD

CONTACT

86 13917073226; blw_betty@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: March 19, 2026
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)